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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameINNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM
Classification Namestent, superficial femoral artery
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP140028
Date Received12/10/2014
Decision Date07/21/2015
Product Code
NIP[ Registered Establishments with NIP ]
Advisory Committee Cardiovascular
Clinical Trials NCT01292928
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the innova vascular self-expanding stent system. This device is indicated for: the innova¿ vascular self-expanding stent system is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (sfa) and/or proximal popliteal artery (ppa) with reference vessel diameters from 4. 0 mm to 7. 0 mm and lesion lengths up to 190 mm.
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